NINDS Biotechnology Products and Biologics Discovery and Development Consulting Services 14-105 STATEMENT OF WORK A. Background The National Institute of Neurological Disorders and Stroke (NINDS) is a part of the National Institutes of Health (NIH), conducting research into the causes, treatment, and prevention of neurological disorders and stroke. The NINDS mission is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease. NINDS intramural labs are headed by federal employees who work for the Institute, primarily located in Bethesda, MD. For more information on the NINDS Intramural program visit the website http://dir1.ninds.nih.gov/ninds/Home.aspx For extramural research, NINDS awards grants and cooperative agreements to outside academic institutions, small business concerns and other organizations all over the U.S. and world to fund promising basic, translational, and clinical research projects. Specifically, the NINDS Office of Translational Research (OTR) is committed to facilitate the translation of basic discoveries into the development of new therapeutic interventions through nonclinical development and early clinical investigation. Recently, OTR launched a modality specific program, the Cooperative Research to Enable and Advance Translational Enterprises for Biotechnology Products and Biologics (CREATE Bio). This new program is dedicated to support the discovery and development of biologics-based therapies - such as peptides, proteins, antibodies, oligonucleotides, gene therapies, and cell therapies. The program distinguishes between two tracks: a Discovery Track supporting lead optimization and a Development Track supporting IND-enabling studies that may include early-phase clinical trials. For more information about the CREATE Bio Program visit the website (http://www.ninds.nih.gov/funding/areas/translational_research/CREATE-Bio.htm). Since CREATE Bio projects are funded through a cooperative agreement award mechanism, a collaborative team is formed between the principal investigators (PI) group with NINDS program staff participation in guiding the project plan. The PI?s team performs all of the experiments while NINDS role is to establish performance milestones for each project to facilitate go/no-go decision making and then monitor research progress and achievement of project milestones. STATEMENT OF OBJECTIVE The NINDS is seeking senior-level, industry-experienced discovery and development consultants with expertise in biotechnology products and biologics to assist NINDS program staff to vet and advance only the most promising therapeutic biologics through the development pipeline. Consultants with the following individual or combined areas of expertise are encouraged to propose their services: ? Biologics Regulatory Affairs Consultant ? Biologics CMC Development Consultant 1 of 6 B. SCOPE OF WORK Each consultant is expected to provide technical guidance and advice pertaining to their area of expertise on advancing discovery and development projects through nonclinical development and submission of an IND or BLA package, and in some cases, design of early clinical protocol and launch of a first in human clinical trial. Consulting services will be for biologics-focused projects from the Cooperative Translational Research program such as CREATE Bio, Intramural NINDS projects or any other NINDS program with similar needs as outlined in the scope of this statement of work. Consulting contracts will include as many areas of expertise as possible as outlined in this Statement of Work, and will reflect the NIH time commitment and needs for the specific areas of expertise. Consultants will be expected to provide feedback and guidance on projects to NINDS staff through written documents, conference calls, and by email. The consultants? major responsibility will be in offering review, guidance and advice on projects. They will be expected to offer technical review and feedback on project milestones, progress reports, or development plans, study design, and data interpretation. Specific consulting responsibilities will depend on the expertise of the individual consultant and the needs of individual projects. On rare occasion, consultants may be asked to give oral presentations to NINDS staff or at an NINDS sponsored webinar, workshop or conference to provide training to investigators in their area of expertise. General Requirements Consultants will be asked to provide strategic and expert technical guidance for biotechnology products and biologic discovery and development projects. Consultants will serve as a resource to NINDS staff from the start of early discovery stage projects to structurally modify and optimize design characteristics of leads through IND-enabling activities necessary to advance potential development candidates through scale up and early phase clinical trials. Consulting advice and guidance shall be required to supplement NINDS program experience from the pre-application stage and then throughout the life of each project to review and monitor progress. Each project team is led by a PI and supported by NINDS staff with disease and therapy development expertise. The joint team establishes project milestones and monitors progress at least annually. The PIs conduct all of the research activities and report progress to NINDS. NINDS staff will interact directly with the PI and request assistance from consultants to review and provide expert advice on specific topics. Consultants shall directly advise NINDS staff, and in some cases communicate directly with the PI on team calls. Specific Discipline Requirements 1. Biologics Regulatory Affairs The role of the biologics regulatory consultant shall include, but is not limited to, the following responsibilities and tasks: ? Advise NINDS staff on CDER and CBER regulatory guidelines, regulations, and requirements pertaining to the nonclinical and early clinical development of biologics ? Review and assess data and project related proposals, and advise on study requirements to file an IND package for a range of potential biologics therapeutic 2 of 6 modalities in nonclinical IND-enabling development ? such as peptides, antibodies, recombinant proteins, oligonucleotides, cell and gene therapies - based on regulatory precedence and compliance to Common Technical Document (CTD) format requirements, including: o Review of administrative information (e.g. target product profiles, clinical protocols, and investigator information) o Review of animal pharmacology and toxicology study results to assess whether the product is expected to be reasonably safe for initial testing in humans o Determine if previous relevant human experience is available for similar biologics or research and report results from relevant clinical trials conducted both inside and outside of the US. o Review chemistry, manufacturing and control (CMC) nonclinical study plans and results pertaining to the composition, manufacturing, testing, stability and controls for a range of biologics to assess compliance to regulatory guidance. o Review clinical protocols and investigator information to assess adherence to investigational regulations and study protocols as it pertains to a biologic modality in each case. ? Provide guidance to the preparation of pre-IND and IND Meetings or review FDA responses to recommend new course of action. ? Identify and assess regulatory risks and gaps to IND-enabling research study plans and recommend solutions ? Give oral presentations in area of expertise 2. Biologics Chemical Manufacturing and Controls (CMC) Development The role of the biologics CMC consultant may include, but is not limited to, the following responsibilities and tasks: ? Provide guidance to NINDS staff on all CMC related requirements of the nonclinical and early clinical development of biologics (such as peptides, antibodies, recombinant proteins, oligonucleotides, and cell and gene therapies) in accordance with the US regulatory and the ICH guidelines. ? Review and comment on the adequacy of biologic manufacturing including scale-up, analytical method development, and process development (upstream and downstream processing) approaches proposed by investigators ? Provide expert advice, risk and gap analysis to team related to all CMC aspects such as proposed analytical strategy, QC release methods requirements, formulation development, stability testing, stage appropriate assay requirements such as potency and viral clearance ? Provide guidance on delivery methods which may include complex formulations such as polymer, liposomes, and nanoparticles ? Provide expert advice on master and working cell and viral bank development and testing ? Give oral presentations in area of expertise C. QUALIFICATIONS General Experience 3 of 6 ? Consultants must have extensive experience in providing expert advice for biotechnology and biologic discovery and development projects clients in the biopharmaceutical industry or academia. Experience with biotechnology products and biologic discovery for nervous system conditions is preferred but not required. ? Consultants must have strong interpersonal skills, an attention to detail, excellent organizational, writing, communication, presentation, and documentation skills. ? Consultants must have knowledge and understanding of global regulatory regulations and guidelines pertaining to the nonclinical and early clinical development of biologics. ? Individual subject matter experts or multidisciplinary teams from consulting firms are encouraged to apply. Specific Discipline Experience The following experience requirements are the minimum acceptable requirements for each consulting category: 1. Biologics Regulatory Affairs Consultant: ? A minimum of 10 years? experience in the biotechnology, pharmaceutical industry or regulatory industry is required. ? A minimum of 7 years hands-on and in-depth consulting experience in nonclinical and clinical development of biologics ? Demonstrate high-level expertise working with CBER and/or CDER pertaining to development of biologics ? Familiar with FDA guidance documents pertaining to development of biologics ? A good understanding of chemistry, analytics and pharmaceutical technology and in-depth understanding of the biologic therapeutic development process. ? Proven track record of early recognition of potential regulatory risks especially with IND filings for biologics and proposing solutions ? FDA interactions and experience reviewing of Pre-IND and IND applications for outside organizations. 2. Biologics CMC Development Consultant: ? A PhD or equivalent in a biological science or chemistry degree preferred ? At least 10 years of CMC experience; biotechnology products and biologics experience required ? Previous hands-on experience in the preparation and/or review of the CMC sections of pre-IND, IND and/or BLA for biologics ? A good understanding and track record of developing and advising clients on analytical assays and release assay development requirements for the nonclinical and clinical development of different biologic modalities ? A good understanding of US regulatory requirements pertaining to nonclinical and clinical CMC development of different biologic modalities ? Familiar with FDA guidance documents pertaining to CMC development of biologics Level of Effort 4 of 6 Each consulting contract will be tailored to the individual consultant?s areas of expertise and desired time commitment. NINDS program staff will contact a consultant when their expertise is needed by email or telephone. Consultants may review and provide input prior to award, and after award on milestones and progress report, and to a minor degree advise NINDS staff on overall strategy. The NIH estimates that it will require the following labor hours and number of consultants for each of the specific disciplines as follows: Regulatory Affairs and Clinical Year 1: Up to 20 hours Year 2: Up to 180 hours Year 3: Up to 180 hours Year 4: Up to 180 hours Year 5: Up to 180 hours Chemical Manufacturing and Controls (CMC/Pharmaceutics) Year 1: Up to 20 hours Year 2: Up to 180 hours Year 3: Up to 180 hours Year 4: Up to 180 hours Year 5: Up to 180 hours 3. Period of Performance Base Year - May 1, 2015 through April 31, 2016 Option Period One - May 1, 2016 through April 31, 2017 Option Period Two ? May 1, 2017 through April 31, 2018 Option Period Three ? May 1, 2018 through April 31, 2019 Option Period Four - May 1, 2019 through April 31, 2020 4. Travel In general, consultants shall furnish their own equipment and provide a place to work. Under special circumstances, consultant may be asked to give presentations in area of expertise to train program staff or investigators. Travel reimbursement will be provided for when giving presentations. The consultant shall make his/her own travel arrangements. The COR shall assist the consultant in identifying a hotel at an acceptable rate, if an overnight stay is required. The Government shall reimburse all reasonable travel costs. Airplane tickets must be purchased from a US carrier, at the coach/economy rate. The Government shall reimburse hotel costs for up to two nights per site visit, as well as food and incidental expenses. The consultant shall make a good faith effort to select travel options that are the most time and cost-effective, given the available options. The consultant shall make a good faith effort to keep food and incidental costs within the typical government per diem rate for the region. The consultant may bill up to 50% of travel hours to the Government, at the negotiated consulting rate. 5. Confidential Treatment of Sensitive Information 5 of 6 Consultant(s) must guarantee strict confidentiality of the information/data that is provided by the NINDS or by any other participant on a project to which the consultant is assigned. The NINDS has determined that the information/data that the consultant will be provided during the performance of the consulting contract is of a sensitive nature. Consultant(s) may only disclose the information/data generated for a particular project to other participants on that same project. These specific individuals will be identified when the consultant is assigned to a project. Disclosure of the information/data, in whole or in part, by the consultant to anyone else can only be made after the consultant receives prior written approval from the Contracting Officer. Whenever the consultant is uncertain with regard to the proper handling of information/data under the contract, the consultant shall obtain a written determination from the Contracting Officer. Contractor agrees that it will not use the Confidential Information for any purpose except as set forth within this SOW, unless such time as such Confidential Information becomes public information. IT Security Requirements Please refer to the solicitation for IT Security Requirements. The NIH anticipates awarding multiple consulting contracts under this solicitation. 6 of 6